Official Title
Seroprevalence of Antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) in a Vulnerable Neighbourhood, Buenos Aries Argentina
Brief Summary

Background The study aimed to establish the seroprevalence of SARS-COV-2 in an Argentinian slum three months after the first case was reported. Methods Between June 10th and July 1st, a cross-sectional design was carried out on people over 14 years old, selected from a probabilistic sample of households. Finger prick puncture ELISA test

Detailed Description

A community-level seroprevalence survey was conducted in a cross-sectional design during a
Participatory Action Research (PAR).

Starter PAR team: researcher who developed the Elisa Test, virologist that perform the
analysis of the test and physician that served as volunteer field epidemiologist at the
surveillance system (DetectAr Barrio 31) offered technical cooperation to test people
experiencing homelessness.

PAR-First step: A sample for convenience of homeless people was tested during 3 days in a
popular dining room managed by a non-governmental organization. Samples were collected by a
DetectAr nurse and a volunteer epidemiologist.

PAR-Second step: feasibility was determined by the DetectAr coordinators of the Community
Health Division of the Ministry of Health and the 12 health community workers (HCWs) when two
volunteer epidemiologists from a University Institute explained the field organization
(sample technique, data collection and database entry) for obtaining a probabilistic sample
of residents. The PAR process was a cornerstone for reaching the sample size.

PAR-Third step: A cross-sectional study for seroprevalence survey was carried out.

Sample size and sample method Sample size was calculated for a seroprevalence of 5% according
to evidence. A two-stage random sampling method was applied. First level: sector of the slum,
Second level: geographical areas determined by the Department of Statistic and Census. Thirty
houses were selected at this level. People over 14 years old were tested at the front door of
their houses.

Serological test An enzyme linked immunosorbent assay [ELISA] developed in Argentina, by a
laboratory in Buenos Aires, Argentina, was used. Performance characteristics are a high
specificity (>95%) and a high sensibility (>95%) for SARS-COV-2 IgG. The test detects
antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD)
of the spike. Viral proteins were expressed in human cells. This kit has obtained regulatory
approval by Argentina's national drug regulatory agency (ANMAT, National Administration for
Drugs, Food and Medical Devices)[. Blood samples were collected in a capillary tube from a
finger prick, taken at the front door of each house. All HCWs were trained and
epidemiological data was entered in a database. Samples were processed and analyzed at the
virology laboratory in a pediatric hospital of Buenos Aires.

Statistical analysis To obtain the weighted prevalence, sample dataset was expanded to that
of the last census by 3 factors: at neighborhood level, at household level and at individual
level. The calculation of expansion factors at the household level is the inverse of the
joint probability of selecting the last sampling unit (a household). The expansion factors at
the household level imply three types of adjustments. The first one is related with
non-response (given that some households did not want to answer the survey); the second one
corresponds to the projection of sample to the entire population, and the third one to
calibration techniques with a final adjustment by groups of age and gender, using external
information from population census. Therefore, calibration variables were people 14 year-old
or more, grouped by sex and by intervals of age: 14-30; 31-45; 46-59; 60 and more.

Prevalence of IgG antibodies were adjusted using sampling weights and post-stratification to
allow for differences in non-response rates based on age group, sex, and census-tract income.

As household members share exposure to COVID-19, thus the outcome (prevalence of COVID-19
IgG) should show some correlation within the household. To test clustering effect, a random
effects logistic regression model (multilevel model) was applied as it includes the variation
between clusters explicitly in the likelihood and therefore takes account of intracluster
correlation.

Completed
SARS-CoV-2

Diagnostic Test: Serological Assay or IgG for SARS-CoV-2

Serological Assay for detection of IgG for SARS-CoV-2

Eligibility Criteria

Inclusion Criteria:

- All subjects of 14 years or more who accept to be test

Exclusion Criteria:

- none

Eligibility Gender
All
Eligibility Age
Minimum: 14 Years ~ Maximum: N/A
Countries
Argentina
Locations

Hospital de Niños Ricardo Gutierrez
Buenos Aires, Caba, Argentina

Hospital Italiano de Buenos Aires
NCT Number
Keywords
Slums
Seroprevalence study
Participatory Research
Coronavirus
Community health
Clustering
MeSH Terms
Coronavirus Infections